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Applying Novel Technologies and Methods to Inform the Ontology of Self-Regulation: Binge Eating and Smoking

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ClinicalTrials.gov Identifier: NCT03353649
Recruitment Status : Recruiting
First Posted : November 27, 2017
Last Update Posted : August 24, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Russell Alan Poldrack, Stanford University

Brief Summary:
This study aims to examine targets of self-regulatory function among two exemplar populations for which behavior plays a critical role in health outcomes: smokers and individual who binge eat (BED). This is the second phase of a study that aims to identify putative mechanisms of behavior change to develop an overarching "ontology" of self-regulatory processes.

Condition or disease Intervention/treatment Phase
Binge Eating Smoking, Tobacco Behavior Behavioral: Now vs. Later Cue Device: fMRI Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Applying Novel Technologies and Methods to Inform the Ontology of Self-Regulation: Binge Eating and Smoking
Actual Study Start Date : December 8, 2017
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: Binge Eating Group

(1) exposing subjects to specific stimulus sets relevant to the sample that may promote engagement of appetitive drives (images of highly palatable foods for obese individuals), and (2) exposing them to an instructional manipulation designed to engage self-regulatory processes in the presence of these stimulus sets. Specifically, participants in this sample will be exposed to images of food and control non-food images. In different trials, subjects will be given a "now" cue instructing them to engage with the immediate hedonic properties of the stimulus or a "later" cue instructing them to imagine the long-term consequences of using the stimulus.

This arm includes fMRI and the now vs. later cue intervention

Behavioral: Now vs. Later Cue
As we collect data from all participants, we will include manipulations (or "motivating operations") meant to modulate putative targets within the self-regulation domain in each clinical group - to assess the extent to which we can shift self-regulatory function both in desired and undesired directions. More specifically, subjects will see a "now" cue instructing them to think of immediately using/consuming that stimulus or a "later" cue instruction them to think about the long-term consequences of using/consuming that stimulus. The latter cue is intended to down-regulate desire to use/consume the stimulus, and this down-regulation is measured by a subsequent probe asking subjects the degree to which they want to use/consume that stimulus.

Device: fMRI
Subjects will complete the tasks inside a functional magnetic resonance imaging device, allowing us to measure brain activity that while completing each task.

Experimental: Smoking Group

(1) exposing subjects to specific stimulus sets relevant to the sample that may promote engagement of appetitive drives (tobacco-related images or smokers), and (2) exposing them to an instructional manipulation designed to engage self-regulatory processes in the presence of these stimulus sets.

A similar approach to the Binge Eating sample will be used for the smoking sample using two stimulus sets. Instead of foods and non-food control images, smokers will see smoking-related images and the same control non-food non-smoking images as the Binge Eating sample.

This Arm includes fMRI and the now vs. later cue intervention

Behavioral: Now vs. Later Cue
As we collect data from all participants, we will include manipulations (or "motivating operations") meant to modulate putative targets within the self-regulation domain in each clinical group - to assess the extent to which we can shift self-regulatory function both in desired and undesired directions. More specifically, subjects will see a "now" cue instructing them to think of immediately using/consuming that stimulus or a "later" cue instruction them to think about the long-term consequences of using/consuming that stimulus. The latter cue is intended to down-regulate desire to use/consume the stimulus, and this down-regulation is measured by a subsequent probe asking subjects the degree to which they want to use/consume that stimulus.

Device: fMRI
Subjects will complete the tasks inside a functional magnetic resonance imaging device, allowing us to measure brain activity that while completing each task.




Primary Outcome Measures :
  1. Behavioral Regulation [ Time Frame: A single 1.5 hour session for each subject ]
    Interaction of stimulus class, which is the stimulus of value (smoking stimuli for smokers and palatable foods for binge eaters) vs. neutral control stimuli, with the cue, which is the now vs. later cue. The degree to which subjects can regulate their desire to consume their stimulus of value after a later cue is evidence of successful self regulation.

  2. Regulation of fMRI activation [ Time Frame: A single 1.5 hour session for each subject ]
    Interaction of stimulus class, which is the stimulus of value (smoking stimuli for smokers and palatable foods for binge eaters) vs. neutral control stimuli, with the cue, which is the now vs. later cue. The fMRI activation relating to this interaction is taken as the activation-based neural underpinnings of self-regulation.

  3. Changes in fMRI functional connectivity [ Time Frame: A single 1.5 hour session for each subject ]
    Interaction of stimulus class, which is the stimulus of value (smoking stimuli for smokers and palatable foods for binge eaters) vs. neutral control stimuli, with the cue, which is the now vs. later cue. The fMRI functional connectivity changes relating to this interaction is taken as the connectivity-based neural underpinnings of self-regulation.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Understand English sufficiently to provide informed consent
  • Right-handed
  • Normal or corrected-to-normal vision and no color blindness

Additional Inclusion Criteria for Smoking sample:

  • Smoke 5 or more tobacco cigarettes/day for past year
  • BMI greater than or equal to 17 and less than 27

Additional Inclusion Criteria for Binge Eating Sample:

  • BMI greater than or equal to 27 and less than 45
  • Weight limit of 350 lbs
  • Non-smoking (defined as no cigarettes in past 12 months—this includes former and never smokers)

Exclusion Criteria:

  • Significant medical illness
  • History of mental disorder due to a medical condition
  • Lifetime history of major psychotic disorders (including schizophrenia and bipolar disorder)
  • Current use of any medication for psychiatric reasons (including stimulants and mood stabilizers)

Additional Exclusion criteria for Binge Eating Sample:

  • Lost weight in recent past (>10 pounds in past 6 months)
  • Currently in a weight-loss program (e.g., Weight Watchers, Jenny Craig)
  • Currently on a special diet for a serious health condition

Additional Exclusion Criteria for Smoking Sample:

  • Binge eating behavior

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353649


Contacts
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Contact: Russell A Poldrack, PhD 650-497-8488 russpold@stanford.edu
Contact: Patrick G Bissett, PhD pbissett@stanford.edu

Locations
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United States, California
Stanford CNI Recruiting
Stanford, California, United States, 94305
Contact: Laima Baltusis    650-725-8382    laimab@stanford.edu   
Principal Investigator: Russell A Poldrack         
Sub-Investigator: Patrick Bissett         
Sub-Investigator: Michaela Kiernan         
Sub-Investigator: Judith Prochaska         
Sub-Investigator: Sadev Parikh         
Sub-Investigator: Amy Chieng         
Sub-Investigator: Jamie Li         
Sponsors and Collaborators
Stanford University
National Institute on Drug Abuse (NIDA)

Publications:
Stroop, J. R. (1935). Studies of interference in serial verbal reactions. Journal of Experimental Psychology, 18, 643-662.
Daugherty, J. R., & Brase, G. L. (2010). Taking time to be healthy: Predicting health behaviors with delay discounting and time perspective. Personality and Individual differences, 48(2), 202-207.

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Responsible Party: Russell Alan Poldrack, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03353649     History of Changes
Other Study ID Numbers: 5UH2DA041713-02 ( U.S. NIH Grant/Contract )
UH2DA041713 ( U.S. NIH Grant/Contract )
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all outcome measures will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Upon submission of the paper detailing the findings of the research
Access Criteria: All data will be shared openly, with no restrictions on access

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Bulimia
Binge-Eating Disorder
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders